Expanded Haploidentical Natural Killer Cells as Consolidation Strategy for Children/Young Adults With AML

  • End date
    Jun 4, 2026
  • participants needed
  • sponsor
    Belarusian Research Center for Pediatric Oncology, Hematology and Immunology
Updated on 4 May 2022
consolidation therapy


The purpose of this study is to estimate the efficacy of immunotherapy with ex vivo expanded haploidentical NK cells as consolidation therapy for children/young adults with intermediate risk AML.


Immunotherapy with NK cells may improve the treatment results in AML. For better efficiency high cell doses or several infusions of NK cells are required. For this purpose, donor NK cells are expanded in the presence of feeder K562-mbIL21-41BBL cell line. The cycle of immunotherapy includes chemotherapy (cyclophosphamide, fludarabine) followed by two doses of NK cells infusion.

Condition Acute Myeloid Leukemia
Treatment Expanded haploidentical NK cells
Clinical Study IdentifierNCT05334693
SponsorBelarusian Research Center for Pediatric Oncology, Hematology and Immunology
Last Modified on4 May 2022


Yes No Not Sure

Inclusion Criteria

primary intermediate risk AML in molecular complete remission
primary high risk AML in molecular complete remission awaiting unrelated HSCT
Karnofsky or Lansky performance scale greater or equal to 70
written informed consent
haploidentical family donor
donor suitable for cell donation and apheresis according to standard criteria
written informed consent

Exclusion Criteria

uncontrolled infection
severe hepatic dysfunction: SGOT or SCPT >=5x upper limit of normal for age
positive serology for human immunodeficiency virus (HIV)
positive serology for HIV, hepatitis B or C
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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